The Certified Pharmaceutical GMP Professional understands the good manufacturing practices (GMP) as regulated and guided by national and international agencies for the pharmaceutical industry. This covers finished human and veterinary drugs and biologics, ectoparasiticides, and dietary supplements (alternatively called nutraceuticals) where regulated as drug products, as well as their component raw materials (includes active pharmaceutical ingredients (APIs) and excipients), and packaging, and labeling operations.
Employees who have obtained certification as a Pharmaceutical GMP Professional have a demonstrated, extensive, and proven knowledge of the quality system, ensuring that high-quality products are delivered to the consumer. With their breadth of knowledge, employees holding a CPGP can support nearly any aspect of your company’s business and deliver exceptional performance.
- Will have a fundamental understanding of requirements and consequences of noncompliance of regulatory agency governance, including global regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.
- Will be able to understand, apply, and evaluate elements and requirements of a quality system. Will be able to understand and evaluate self-inspection, audits, and supplier management. Will be able to evaluate records, documents, and reports created within these quality systems.
- Will be able to understand, apply, analyze, and evaluate requirements, specifications, and data relating to laboratory systems, including relevant compendia for the United States, Europe, and Japan, investigations of atypical laboratory results, and instrument control and record-keeping. Must be able to apply and evaluate stability and sample retain programs. Will be able to apply requirements, specifications, and qualification and validation for construction and maintenance of facilities, utilities, and equipment. Evaluate automated or computerized systems, and apply business continuity plans, disaster recovery techniques, and change management.
- Will be able to apply sampling plans and procedures for shipping and receiving materials, analyze inhouse storage, identification, and rotation of materials, and meet requirements for materials traceability and sourcing, including returned goods.
- Will have a thorough under-standing of sterile and nonsterile requirements of manufacturing systems and be able to analyze master and completed batch records, material control procedures, and contamination controls.
- Will be able to create and evaluate filling, packaging, and labeling operations and controls.
- Will have a fundamental understanding of product design factors and phase-appropriate GMP requirements. Will have a thorough understanding of technology transfer activities.
- Test your knowledge in the eight main domains of the CPGP Body of knowledge
- Become familiar with questions similar to those within the ASQ CPGP exam
- Help guide your study by identifying areas of strengths and weaknesses as it pertains to the CPGP Body of Knowledge
WHO SHOULD ATTEND?
Common job functions: Auditing, Inspection, Manager, Quality Assurance, Supervisor, Technician
Common industries: Government, Medical Devices, Packaging, Pharmaceutical Manufacturing, Service
I. Regulatory Agency Governance
II. Quality Systems
III. Laboratory Systems
IV. Infrastructure: Facilities, Utilities, Equipment
V. Materials and Supply Chain Management
VI. Sterile and Nonsterile Manufacturing Systems
VII. Filling, Packaging, Labeling
VIII. Product Development and Technology Transfer